Corcept Therapeutics (CORT +0.65%) took its investors for quite a ride on Hump Day. The commercial-stage biotech earned its latest nod from a regulator that afternoon and, not surprisingly, its shares leaped skyward on the news. By the end of the day, they had risen by almost 20% in value.
The FDA says yes to Lifyorli
Corcept announced that the U.S. Food and Drug Administration (FDA) approved its Lifyorli, in combination with the chemotherapy drug nab-paclitaxel, for the treatment of the platinum-resistant stages of ovarian, fallopian tube, and primary peritoneal cancer. The approval covers adults who have previously been administered one to three prior systemic treatment regimens.
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According to the company, the FDA's green light was based on the encouraging outcomes of Lifyorli's Rosella trial. This involved 381 patients who were administered the combination therapy, or Lifyorli alone.
Corcept focuses on therapies involving the modulation of cortisol, the so-called "stress hormone" that regulates a number of the body's functions. It's clearly going to continue pursuing that strategy. The company quoted CEO Joseph Belanoff as saying that "Today's approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment."
NASDAQ: CORT
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Betting on future wins
One advantage of the biotech sector is that its victories can be clear and significant. This isn't Corcept's first time at the rodeo (it received its first FDA approval in 2012), but Lifyorli's win not only gives the company a high-potential product in the cancer segment, but it also validates its unique focus on cortisol. I have no trouble imagining more approvals for the biotech in the coming years.
